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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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201 to 210 of 416 results
Decision Date To: 06/01/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Invitae Common Hereditary Cancers Panel Invitae Corporation DEN210011 09/29/2023
Neoasis Invictus Medical, Inc. DEN220048 06/16/2023
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
VerTouch Spinal Imaging Device IntuiTap Medical, Inc. DEN220009 01/19/2024
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
LOADPRO™ Intraoperative Rod Strain Senso Intellirod Spine, Inc. DEN180012 03/28/2019
ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited DEN220024 10/18/2022
HemosIL Liquid Anti-Xa Instrumentation Laboratory Co. DEN190032 09/17/2020
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI INOVA DIAGNOSTICS, INC. DEN000007 K000732 08/16/2000
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